Phase 2 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people with kidney damage caused by multiple myeloma (cast nephropathy):

• People who have been diagnosed with newly diagnosed multiple myeloma (MM) according to standard international guidelines
• People whose myeloma can be measured through blood or urine tests, with results taken within the past 14 days meeting at least one specific threshold for abnormal proteins in the blood or urine
• People whose kidneys are functioning at a significantly reduced level (eGFR below 40 ml/min/1.73m²)
• People who have had a kidney biopsy confirming myeloma-related kidney damage, OR, if no biopsy is available, whose urine and blood protein levels meet specific criteria (confirm with trial site)

For people with kidney disease caused by other monoclonal gammopathy-related conditions (MGRS):

• People who have had a kidney biopsy confirming MGRS-related kidney disease
• People with an abnormal protein detected in the blood through specific laboratory tests
• People whose bone marrow biopsy has confirmed an abnormal plasma cell population
• People with significantly reduced kidney function (eGFR below 40 ml/min/1.73m²) or high levels of protein in the urine over a 24-hour collection period

For all participants:

• People aged 18 or older at the time of registration
• People who are reasonably able to carry out daily activities, rated 0, 1, or 2 on a standard medical fitness scale, assessed within 14 days before registration
• People with no clear recent exposure to substances known to harm kidneys (such as anti-inflammatory painkillers or contrast dye used in scans)
• People with no sign of a blockage in the urinary tract, confirmed by ultrasound
• People with adequate blood counts within 14 days before registration, including sufficient white blood cells, platelets, and haemoglobin levels, without recent use of certain blood-boosting medications or recent blood transfusions (confirm specific thresholds with trial site)
• People with adequate liver function based on blood tests taken within 14 days before registration, meeting specific thresholds for liver enzymes and bilirubin (confirm with trial site)
• Women who are past menopause (for at least one year), have been surgically sterilised, or who agree to use two effective methods of contraception simultaneously from the time of signing the consent form until 90 days after the last dose of the study drug
• Women of childbearing potential who have a negative pregnancy blood test within 14 days before registration and who agree to ongoing pregnancy testing during the trial
• Women who prefer abstinence as their usual lifestyle, provided it is consistent and not periodic (confirm acceptable methods with trial site)
• Men, including those who have had a vasectomy, who agree to use effective barrier contraception throughout the study and for 90 days after the last dose, or who prefer abstinence as their usual lifestyle (confirm acceptable methods with trial site)
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and procedures

Who may not be able to join:

• People whose kidney-related condition is linked to blood cancers other than plasma cell disorders, such as chronic lymphocytic leukaemia, B-cell cancers, or Waldenström's macroglobulinaemia
• People who have plasma cell leukaemia, AL amyloidosis, or POEMS syndrome
• People who have previously received treatment specifically targeting their plasma cell disorder
• People who have previously received, or are currently receiving, other experimental treatments targeting their plasma cell disorder
• Women who are breastfeeding or who have a positive pregnancy test during the screening period
• People who have had major surgery within 14 days before registration
• People who have had focused radiation therapy within 14 days before registration (with some exceptions for palliative symptom relief — confirm with trial site)
• People whose myeloma has spread to the central nervous system (brain or spinal cord)
• People with an active, uncontrolled infection or other serious ongoing illness
• People with significant heart disease, including a heart attack in the past 6 months, uncontrolled heart failure, unstable chest pain, or uncontrolled irregular heart rhythm
• People with any serious medical or mental health condition that, in the doctor's opinion, could interfere with completing the treatment
• People with a known allergy to any of the study medications or their ingredients
• People with another active cancer, except for certain low-risk or previously treated cancers such as non-melanoma skin cancer, early-stage cervical cancer, or low-risk prostate cancer being monitored without treatment
• People with moderate or severe nerve damage in their hands or feet (grade 2 or higher peripheral neuropathy) identified during screening
• People who have received chemotherapy within 14 days before registration
• People who have received another experimental drug or used an experimental medical device within 4 weeks, or within 5 half-lives of that drug (whichever is longer), before registration
• People with chronic obstructive pulmonary disease (COPD) where breathing tests show lung function below 50% of the expected normal level
• People with moderate or severe persistent asthma in the past 2 years, or any asthma that is currently uncontrolled (people with mild, well-controlled asthma may still be eligible — confirm with trial site)
• People who have a medical reason preventing them from taking blood-thinning or anti-clotting medications
• People currently taking certain medications that strongly affect the way specific liver enzymes process drugs (strong CYP3A4 or CYP1A2 inducers or inhibitors — confirm with trial site)
• People with moderate or severe liver disease based on a standard liver scoring system (Child-Pugh score B or C); people with score A are excluded from one part of the trial but may be eligible for another part (confirm with trial site)
• People with a known history of HIV, or who test positive for HIV
• People who test positive for active hepatitis B infection, or who have certain markers suggesting past hepatitis B infection with detectable virus levels on further testing (confirm specific exceptions with trial site)
• People who test positive for hepatitis C, unless they have completed antiviral treatment and had no detectable virus for at least 12 weeks afterwards
• People who have received a live attenuated vaccine within 4 weeks before starting the study
• People who have undergone plasmapheresis (a blood-filtering procedure) within 28 days before randomisation

Important: Always verify eligibility with the trial site directly before applying.